caffeine citrate

Product NDC
25021-602
11-digit product format
250210602
Labeler code
25021
Product ID
25021-602_059be7d2-16bf-4197-a4b2-5a05540d6b82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
caffeine citrate
Dosage form
SOLUTION
Route
ORAL
Labeler
Sagent Pharmaceuticals
Application
ANDA091102
Marketing category
ANDA
Marketing start
2012-09-15
Substance
CAFFEINE CITRATE
Active strength
20 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091102-001CAFFEINE CITRATECAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091102-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091102-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORALAA2012-08-29e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091102-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091102-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091102-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091102-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091102-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091102-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091102-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091102-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091102-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091102-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091102-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091102-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091102-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091102-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091102-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091102-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091102-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091102-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091102-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091102-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091102-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091102-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091102-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091102-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091102-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091102-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091102-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091102-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091102-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091102-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091102-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091102-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091102-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091102-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091102-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091102-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091102-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091102-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091102-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091102-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
caffeine citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE CITRATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U26EO4675QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849928Internal RxNorm lookup
849931Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f38c395-0093-4afd-89ec-f96e5dc0934aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-602-03caffeine citrate3 mL in 1 VIALSOLUTION39
25021-602-03caffeine citrate10 in 1 CARTONSOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-602-03ML - Milliliter25021-6026424bf96-ef29-43f9-803f-82fbd970a1e312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
caffeine citrateACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
caffeineACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6
waterINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-602CAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20210126_5f38c395-0093-4afd-89ec-f96e5dc0934a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
caffeine citrateCAFFEINE CITRATESagent Pharmaceuticals5f38c395-0093-4afd-89ec-f96e5dc0934a2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091102
application number: ANDA091102
ndc (product): 25021-602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSN5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSN5f38c395-0093-4afd-89ec-f96e5dc0934a9
8499313 ML caffeine citrate 20 MG/ML InjectionSCD5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 20 MG/ML Oral SolutionSCD5f38c395-0093-4afd-89ec-f96e5dc0934a9
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9
849931caffeine citrate 60 MG per 3 ML InjectionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9
849928caffeine citrate 60 MG per 3 ML Oral SolutionSY5f38c395-0093-4afd-89ec-f96e5dc0934a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-602-032502106020310 VIAL in 1 CARTON (25021-602-03) / 3 mL in 1 VIAL10 vial2012-09-150000-00-00NoNoCurrent